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Medical Device Recalls
Class 3 Recall
HYDRAGEL 15 Hemoglobin (E)

See Related Information
Date Recall
Initiated		 August 29, 2006
Date Posted October 25, 2006
Recall Number Z-0073-2007
Product HYDRAGEL 15 Alkaline Hemoglobin (E) kit, in vitro diagnostic, Sebia Parc Technologique Leonard de Vinci, Rue Leonard de Vinci, 91090 Lisses, France
Code Information Cat. Number 4126, Lot numbers: 22026/01, 14036/01, 12066/02 and 12066/03.
Recalling Firm/
Manufacturer		 Sebia, Inc.
400-1705 Corporate Dr.
Norcross , Georgia 30093
For Addition Information Contact Karen Anderson
446-3707 Ext. 3704
Reason For
Recall		 The material used in packaging the product results in the presence of an additional artifact band above the HbA fraction.
Action Consignees were notified via fax letter and also by phone contact on or about 08/29/2006.
Quantity in Commerce 71 kits
Distribution Nationwide (AL, CA, CO, FL, GA, IL, KA, LA, MD, MI, NM, NC, NJ, NY, PA, TX, VA, WI) and Puerto Rico
 

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